Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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iNterra™ iNoffice Nightguard Starter Kit
DENTSPLY INTERNATIONAL INC.
61D010
Not in Commercial Distribution

  • D00261D01062 ()
  • D00261D0101 ()

  • Total Volume: 50 Milliliter
  • 1 Small Arch, 2 Medium Arches, 1 Large Arch, 1 Cartridge Regisil® Rigid Super Fast Set Material (50mL), 6 Mixing Tips
61D010

  • Custom-made mouthguard
Megalloy®EZ Spherical Amalgam Self-Activating Capsules - Bulk Jars, 3 Spill Case (Lime Green)
DENTSPLY INTERNATIONAL INC.
603016
Not in Commercial Distribution

  • D0026030162 ()
  • D0026030161 ()
  • D0026030160 ()

  • Weight: 800 Milligram
  • No. 3 Spill Case (Lime Green) 4 Jars of 250 Capsules (800mg alloy each Capsule)
603016

  • Dental amalgam alloy
Megalloy®EZ Spherical Amalgam Self-Activating Capsules - Bulk Jars, 2 Spill Case (Purple)
DENTSPLY INTERNATIONAL INC.
603015
Not in Commercial Distribution

  • D0026030152 ()
  • D0026030151 ()
  • D0026030150 ()

  • No. 2 Spill Case (Purple) 4 Jars of 250 Capsules (600mg alloy each Capsule)
  • Weight: 600 Milligram
603015

  • Dental amalgam alloy
Megalloy®EZ Spherical Amalgam Self-Activating Capsules - Bulk Jars, 1 Spill Case (Red)
DENTSPLY INTERNATIONAL INC.
603014
Not in Commercial Distribution

  • D0026030142 ()
  • D0026030141 ()
  • D0026030140 ()

  • Weight: 400 Milligram
  • No. 1 Spill Case (Red) 4 Jars of 250 Capsules (400mg alloy each Capsule)
603014

  • Dental amalgam alloy
Megalloy®EZ Spherical Amalgam Self-Activating Capsules - 10 Jars, 3 Spill (Lime Green)
DENTSPLY INTERNATIONAL INC.
603006
Not in Commercial Distribution

  • D0026030062 ()
  • D0026030061 ()
  • D0026030060 ()

  • Weight: 800 Milligram
  • No.3 Spill (Lime Green) 10 jars of 50 Capsules (800mg alloy each capsule)
603006

  • Dental amalgam alloy
Megalloy®EZ Spherical Amalgam Self-Activating Capsules - 10 Jars, 2 Spill (Purple)
DENTSPLY INTERNATIONAL INC.
603005
Not in Commercial Distribution

  • D0026030052 ()
  • D0026030051 ()
  • D0026030050 ()

  • No. 2 Spill (Purple): 10 jars of 50 Capsules (600mg alloy each capsule)
  • Weight: 600 Milligram
603005

  • Dental amalgam alloy
Megalloy®EZ Spherical Amalgam Self-Activating Capsules - 10 Jars, 1 Spill (Red)
DENTSPLY INTERNATIONAL INC.
603004
Not in Commercial Distribution

  • D0026030042 ()
  • D0026030041 ()
  • D0026030040 ()

  • Weight: 400 Milligram
  • No. 1 Spill (Red): 10 jars of 50 Capsules (400mg alloy each capsule)
603004

  • Dental amalgam alloy
No Description
Dentsply International Inc.
Dentin C4
Not in Commercial Distribution

  • D0019083551 ()
  • D0019081180 ()

  • Weight: 5 Gram
908118

  • Temporary dental crown/bridge
No Description
Dentsply International Inc.
Dentin i2
Not in Commercial Distribution

  • D0019083451 ()
  • D0019081090 ()

  • Weight: 5 Gram
908109

  • Temporary dental crown/bridge
No Description
Dentsply International Inc.
Dentin D2
Not in Commercial Distribution

  • D0019083401 ()
  • D0019081080 ()

  • Weight: 5 Gram
908108

  • Temporary dental crown/bridge
No Description
Dentsply International Inc.
Dentin C2
Not in Commercial Distribution

  • D0019083501 ()
  • D0019081070 ()

  • Weight: 5 Gram
908107

  • Temporary dental crown/bridge
No Description
Dentsply International Inc.
Dentin B1
Not in Commercial Distribution

  • D0019083351 ()
  • D0019081060 ()

  • Weight: 5 Gram
908106

  • Temporary dental crown/bridge
No Description
Dentsply International Inc.
Dentin A3.5
Not in Commercial Distribution

  • D0019083301 ()
  • D0019081050 ()

  • Weight: 5 Gram
908105

  • Temporary dental crown/bridge
No Description
Dentsply International Inc.
Dentin A3
Not in Commercial Distribution

  • D0019083251 ()
  • D0019081040 ()

  • Weight: 5 Gram
908104

  • Temporary dental crown/bridge
No Description
Dentsply International Inc.
Dentin A2
Not in Commercial Distribution

  • D0019083201 ()
  • D0019081030 ()

  • Weight: 5 Gram
908103

  • Temporary dental crown/bridge
No Description
Dentsply International Inc.
Dentin A1
Not in Commercial Distribution

  • D0019083151 ()
  • D0019081020 ()

  • Weight: 5 Gram
908102

  • Temporary dental crown/bridge
No Description
Dentsply International Inc.
Enamel Medium
Not in Commercial Distribution

  • D0019083101 ()
  • D0019081010 ()

  • Weight: 5 Gram
908101

  • Temporary dental crown/bridge
No Description
Dentsply International Inc.
Enamel Light
Not in Commercial Distribution

  • D0019083051 ()
  • D0019081000 ()

  • Weight: 5 Gram
908100

  • Temporary dental crown/bridge
Pink Natural
Dentsply International Inc.
50-Unit Package
In Commercial Distribution

  • D0019059491 ()
  • D0019059390 ()

  • Weight: 1000 Gram


  • Dental appliance fabrication material, resin
Pink Opaque
Dentsply International Inc.
50-Unit Package
In Commercial Distribution

  • D0019059481 ()
  • D0019059380 ()

  • Weight: 1000 Gram


  • Dental appliance fabrication material, resin
No Description
Dentsply International Inc.
Clear Pour Acrylic
Not in Commercial Distribution

  • D0019059501 ()
  • D0019059400 ()

  • Weight: 1000 Gram
905940

  • Dental appliance fabrication material, resin
Pink Intensive
Dentsply International Inc.
50-Unit Package
In Commercial Distribution

  • D0019059471 ()
  • D0019059370 ()

  • Weight: 1000 Gram


  • Dental appliance fabrication material, resin
Pink
Dentsply International Inc.
50-Unit Package
In Commercial Distribution

  • D0019059461 ()
  • D0019059360 ()

  • Weight: 1000 Gram


  • Dental appliance fabrication material, resin
No Description
Dentsply International Inc.
Liquid
Not in Commercial Distribution

  • D001892601 ()
  • D001892590 ()

  • Total Volume: 950 Milliliter
89259

  • Dental appliance fabrication material, resin
Dycal® Dentin Radiopaque Calcium Hydroxide Composition, Standard Package
DENTSPLY INTERNATIONAL INC.
623802
In Commercial Distribution

  • D00262380262 ()
  • D0026238021 ()

  • Weight: 11 Gram
  • Weight: 13 Gram
  • 1 Base (13g), 1 Catalyst (11g), 1 Mixing Pad
623802

  • Dental composite resin
Dycal® Ivory Radiopaque Calcium Hydroxide Composition, Standard Package
DENTSPLY INTERNATIONAL INC.
623801
In Commercial Distribution

  • D00262380162 ()
  • D0026238011 ()

  • 1 Base (13g), 1 Catalyst (11g), 1 Mixing Pad
  • Weight: 11 Gram
  • Weight: 13 Gram
623801

  • Dental composite resin
Algin-X™ Ultra Alginate Alternative Impression Material, Fast Set, 2 (380ml) DECA™ Cartridge Standard Pack
DENTSPLY INTERNATIONAL INC.
61E810
In Commercial Distribution

  • D00261E81082 ()
  • D00261E8101 ()
  • D00261E8100 ()

  • 2 Cartridges (380ml each), 20 Dynamic Mixing Tips, 1 Bayonet Locking Ring
  • Total Volume: 380 Milliliter
61E810

  • Silicone dental impression material
Algin-X™ Ultra Alginate Alternative Impression Material, Fast Set, 4 (50ml) Cartridge Refill
DENTSPLY INTERNATIONAL INC.
61E800
In Commercial Distribution

  • D00261E80082 ()
  • D00261E8001 ()
  • D00261E8000 ()

  • Total Volume: 50 Milliliter
  • 4 Algin-X™ Ultra Cartridges (50mL each) and 6 Mixing Tips
61E800

  • Silicone dental impression material
iNterra™ iNoffice Nightguard Refill Package, Large Arch, 6
DENTSPLY INTERNATIONAL INC.
61D040
Not in Commercial Distribution

  • D00261D04062 ()
  • D00261D0401 ()
  • D00261D0400 ()

  • 6 iNterra™ Nightguard Arches, Large Arch
61D040

  • Custom-made mouthguard
iNterra™ iNoffice Nightguard Refill Package, Medium Arch, 6
DENTSPLY INTERNATIONAL INC.
61D030
Not in Commercial Distribution

  • D00261D03062 ()
  • D00261D0301 ()
  • D00261D0300 ()

  • 6 iNterra™ Nightguard Arches, Medium Arch
61D030

  • Custom-made mouthguard
Calm-It™ Desensitizer Unit Dose Refill
DENTSPLY INTERNATIONAL INC.
61A004
Not in Commercial Distribution

  • D00261A00432 ()
  • D00261A0041 ()
  • D00261A0040 ()

  • 40 Unit Doses and 1 Unit Dose Holder
61A004

  • Dental cavity varnish
Regisil® PB™ VPS Bite Reg Material (Pink), Cartridge Refill Package
DENTSPLY INTERNATIONAL INC.
619510
In Commercial Distribution

  • D00261951082 ()
  • D0026195101 ()
  • D0026195100 ()

  • Total Volume: 50 Milliliter
  • 4 Cartridges (50mL each), 12 Mixing Tips
619510

  • Silicone dental impression material
Regisil® 2X™ VPS Bite Reg Material (Purple), Cartridge Refill Package
DENTSPLY INTERNATIONAL INC.
619500
In Commercial Distribution

  • D00261950082 ()
  • D0026195001 ()
  • D0026195000 ()

  • 4 Cartridges (50mL each), 12 Mixing Tips
  • Total Volume: 50 Milliliter
619500

  • Silicone dental impression material
Regisil® Rigid Super Fast Set VPS Bite Reg Material (Purple), Cartridge System Refill Package
DENTSPLY INTERNATIONAL INC.
619425
In Commercial Distribution

  • D00261942582 ()
  • D0026194251 ()
  • D0026194250 ()

  • Total Volume: 50 Milliliter
  • 4 Cartridges (50mL each), 12 Mixing Tips
619425

  • Silicone dental impression material
Regisil® VPS Bite Reg Material (Purple), Standard Package
DENTSPLY INTERNATIONAL INC.
619130
Not in Commercial Distribution

  • D002619130102 ()
  • D0026191300 ()

  • Total Volume: 90 Milliliter
  • 1 Tube Base (90mL), 1 tube Catalyst (90mL)
619130

  • Silicone dental impression material
IRM® Caps™ Encapsulated ZOE Intermediate Restorative Material Package
DENTSPLY INTERNATIONAL INC.
610200
In Commercial Distribution

  • D00261020062 ()
  • D0026102001 ()

  • Weight: 0.352 Gram
  • 50 Caps (0.352g each cap)
610200

  • Zinc oxide eugenol dental cement
IRM® Intermediate Restorative Material, Ivory, Standard Package
DENTSPLY INTERNATIONAL INC.
610007
In Commercial Distribution

  • D00261000762 ()
  • D0026100071 ()

  • Standard Package (Ivory): 1 Powder (38g), 1 Liquid (14mL)
  • Weight: 38 Gram
  • Total Volume: 14 Milliliter
610007

  • Zinc oxide eugenol dental cement
IRM® Intermediate Restorative Material - Liquid Refill
DENTSPLY INTERNATIONAL INC.
610004
In Commercial Distribution

  • D00261000462 ()
  • D0026100041 ()

  • Total Volume: 14 Milliliter
  • 1 Bottle (14 mL) IRM® Liquid Refill
610004

  • Zinc oxide eugenol dental cement
IRM® Intermediate Restorative Material - Powder Refill
DENTSPLY INTERNATIONAL INC.
610003
In Commercial Distribution

  • D00261000362 ()
  • D0026100031 ()

  • Weight: 38 Gram
  • Ivory Powder Refill
610003

  • Zinc oxide eugenol dental cement
PoGo® One Step Diamond Micro-Polisher - Polishing Point Refill Package (40)
DENTSPLY INTERNATIONAL INC.
662022
In Commercial Distribution

  • D0026620222 ()
  • D0026620221 ()
  • D0026620220 ()

  • 30 Polishing Points
662022

  • Dental abrasive disk, reusable
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